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WO2005063256A3 - Coating method - Google Patents

Coating method Download PDF

Info

Publication number
WO2005063256A3
WO2005063256A3 PCT/EP2004/053537 EP2004053537W WO2005063256A3 WO 2005063256 A3 WO2005063256 A3 WO 2005063256A3 EP 2004053537 W EP2004053537 W EP 2004053537W WO 2005063256 A3 WO2005063256 A3 WO 2005063256A3
Authority
WO
WIPO (PCT)
Prior art keywords
polymer
coating
granules
coating mixture
mesalazine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2004/053537
Other languages
French (fr)
Other versions
WO2005063256A2 (en
Inventor
Svenn Kluever Jepsen
Gudrun Lasskogen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ferring BV
Original Assignee
Ferring BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ferring BV filed Critical Ferring BV
Priority to EP04804883A priority Critical patent/EP1729779A2/en
Priority to JP2006546162A priority patent/JP4785000B2/en
Priority to CA2544572A priority patent/CA2544572C/en
Priority to US10/583,669 priority patent/US8282958B2/en
Publication of WO2005063256A2 publication Critical patent/WO2005063256A2/en
Publication of WO2005063256A3 publication Critical patent/WO2005063256A3/en
Anticipated expiration legal-status Critical
Priority to US13/606,511 priority patent/US8501226B2/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention concerns a method for coating granules comprising mesalazine, with a coating mixture comprising two polymers, polymer I and polymer II; said polymer I being selected to allow formation of a closing membrane around said granules in the absence of said polymer II, and said polymer II being selected to act as a water-soluble pore former in said coating mixture; wherein a) the amount of polymer I is adjusted to provide a closing membrane in the absence of polymer II, and b) the amount of polymer II in said coating mixture is ad­justed to obtain coated granules which exhibit controlled release of mesalazine. The invention further concerns a product obtainable by the coating method.
PCT/EP2004/053537 2003-12-23 2004-12-16 Coating method Ceased WO2005063256A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP04804883A EP1729779A2 (en) 2003-12-23 2004-12-16 Coating method
JP2006546162A JP4785000B2 (en) 2003-12-23 2004-12-16 Coating method
CA2544572A CA2544572C (en) 2003-12-23 2004-12-16 Method of coating granules containing mesalazine
US10/583,669 US8282958B2 (en) 2003-12-23 2004-12-16 Coating method
US13/606,511 US8501226B2 (en) 2003-12-23 2012-09-07 Coating method

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US53168203P 2003-12-23 2003-12-23
EP03029598.4 2003-12-23
EP03029598A EP1547601A1 (en) 2003-12-23 2003-12-23 Coating method
US60/531,682 2003-12-23

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10/583,669 A-371-Of-International US8282958B2 (en) 2003-12-23 2004-12-16 Coating method
US13/606,511 Continuation US8501226B2 (en) 2003-12-23 2012-09-07 Coating method

Publications (2)

Publication Number Publication Date
WO2005063256A2 WO2005063256A2 (en) 2005-07-14
WO2005063256A3 true WO2005063256A3 (en) 2006-04-13

Family

ID=34530700

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/053537 Ceased WO2005063256A2 (en) 2003-12-23 2004-12-16 Coating method

Country Status (5)

Country Link
US (2) US8282958B2 (en)
EP (2) EP1547601A1 (en)
JP (1) JP4785000B2 (en)
CA (1) CA2544572C (en)
WO (1) WO2005063256A2 (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2359812C (en) 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
US20070059368A1 (en) * 2005-05-31 2007-03-15 Cherukuri S R Modified release formulations of anti-irritability drugs
AR036797A1 (en) 2001-10-15 2004-10-06 Ferring Bv A METHOD TO PREPARE A PHARMACEUTICAL COMPOSITION THAT INCLUDES 5-AMINOSALICILIC ACID TO USE IN THE TREATMENT OF ULCEROSE COLITIS AND CROHN DISEASES
CA2520197A1 (en) 2003-04-23 2004-11-04 Ferring B.V. Sachet for a pharmaceutical composition
RU2297835C1 (en) * 2005-09-26 2007-04-27 Закрытое акционерное общество "Партнер" Preparation for treatment of noninfectious inflammatory intestine diseases
NZ576830A (en) * 2006-11-17 2011-03-31 Shire Dev Inc Method of treatment for inflammatory bowel disease
EP2340812A1 (en) 2009-12-18 2011-07-06 Ferring International Center S.A. Granules for pharmaceutical preparations, methods and apparatus for their production
US10071058B2 (en) * 2012-03-07 2018-09-11 Santarus, Inc. Controlled-release solid dosage forms of mesalamine
US20150164920A1 (en) * 2012-03-30 2015-06-18 Laboratorios Del Dr. Esteve S.A. Controlled release formulation comprising mesalamine
CN102784154B (en) * 2012-09-01 2013-10-09 朱文军 Mesalazine enteric coated tablet and preparation method thereof
CN103989638B (en) * 2014-04-29 2016-04-27 常州市第四制药厂有限公司 A kind of mesalamine sustained release granules and preparation method thereof
CN105456223B (en) * 2015-12-16 2019-01-11 西南药业股份有限公司 Mesalazine sustained release pellet and preparation method thereof and Mesalazine spansule
IT201900018041A1 (en) 2019-10-07 2021-04-07 Sara Pellegrino POLYETHYLENIMMIN WITH N-ACYLATE HYDROXYPYRIDONIC FUNCTION, THEIR SYNTHESIS AND THERAPEUTIC USE

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0148811A1 (en) * 1984-01-10 1985-07-17 Lejus Medical Aktiebolag Pharmaceutical composition
GB2163957A (en) * 1984-08-16 1986-03-12 Sandoz Ltd Anti-asthma compositions containing ketotifen
WO1992011001A1 (en) * 1990-12-19 1992-07-09 Solvay (Societe Anonyme) Oral pharmaceutical composition
US5188841A (en) * 1989-06-16 1993-02-23 Rhone-Poulenc Sante Sustained release pharmaceutical formulations
EP0540813A1 (en) * 1991-06-11 1993-05-12 American Cyanamid Company Sustained release formulations of acetazolamide
WO1998026767A2 (en) * 1996-12-17 1998-06-25 Poli Industria Chimica S.P.A. Site-specific controlled release dosage formulation for mesalamine
WO1999021536A1 (en) * 1997-10-23 1999-05-06 Btg International Limited Controlled release formulations
WO2000044353A1 (en) * 1999-01-29 2000-08-03 Losan Pharma Gmbh Pharmaceutical compositions
WO2001066094A1 (en) * 2000-03-07 2001-09-13 Pharmatec International S.R.L. Controlled release oral solid forms containing mesalazine as active agent

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6048484B2 (en) 1980-05-20 1985-10-28 アルザ・コ−ポレ−シヨン Diffusable activator dispenser
JPS5758631A (en) 1980-09-24 1982-04-08 Toyo Jozo Co Ltd Coating composition
US5254347A (en) 1988-03-31 1993-10-19 Tanabe Seiyaku Co., Ltd. Controlled release pharmaceutical preparation and method for producing the same
US5484605A (en) 1988-11-25 1996-01-16 Henning Berlin Gmbh Chemie-Und Pharmawerk Agent for treating chronically inflammatory intestinal diseases
IT1246382B (en) 1990-04-17 1994-11-18 Eurand Int METHOD FOR THE TARGETED AND CONTROLLED DELIVERY OF DRUGS IN THE INTESTINE AND PARTICULARLY IN THE COLON
US5472712A (en) * 1991-12-24 1995-12-05 Euroceltique, S.A. Controlled-release formulations coated with aqueous dispersions of ethylcellulose
JPH0826977A (en) 1994-07-19 1996-01-30 Tanabe Seiyaku Co Ltd Controlled dissolution oral formulation
KR100598714B1 (en) * 1995-12-21 2006-07-10 파마슈티스크 라보라토리움 페링 에이/에스 Modified release oral pharmaceutical composition containing 5-asa and method for the treatment of bowel diseases
US6245351B1 (en) 1996-03-07 2001-06-12 Takeda Chemical Industries, Ltd. Controlled-release composition
IL118932A0 (en) 1996-07-24 1996-10-31 Dexcel Ltd Controlled release tablets
JP2001055322A (en) 1999-08-18 2001-02-27 Tanabe Seiyaku Co Ltd Pulse release formulation
US6627223B2 (en) * 2000-02-11 2003-09-30 Eurand Pharmaceuticals Ltd. Timed pulsatile drug delivery systems
IT1318625B1 (en) 2000-07-14 2003-08-27 Roberto Valducci ORAL SOLID PHARMACEUTICAL FORMULATIONS WITH MULTI-PHASE RELEASE - EMPLOYEE.
AR036797A1 (en) 2001-10-15 2004-10-06 Ferring Bv A METHOD TO PREPARE A PHARMACEUTICAL COMPOSITION THAT INCLUDES 5-AMINOSALICILIC ACID TO USE IN THE TREATMENT OF ULCEROSE COLITIS AND CROHN DISEASES
ES2288999T3 (en) * 2001-10-15 2008-02-01 Ferring Bv METHOD FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION THAT INCLUDES 5-AMINOSALICILIC ACID FOR USE IN THE TREATMENT OF ULCEROSE COLITIS AND CROHN'S DISEASE.

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0148811A1 (en) * 1984-01-10 1985-07-17 Lejus Medical Aktiebolag Pharmaceutical composition
GB2163957A (en) * 1984-08-16 1986-03-12 Sandoz Ltd Anti-asthma compositions containing ketotifen
US5188841A (en) * 1989-06-16 1993-02-23 Rhone-Poulenc Sante Sustained release pharmaceutical formulations
WO1992011001A1 (en) * 1990-12-19 1992-07-09 Solvay (Societe Anonyme) Oral pharmaceutical composition
EP0540813A1 (en) * 1991-06-11 1993-05-12 American Cyanamid Company Sustained release formulations of acetazolamide
WO1998026767A2 (en) * 1996-12-17 1998-06-25 Poli Industria Chimica S.P.A. Site-specific controlled release dosage formulation for mesalamine
WO1999021536A1 (en) * 1997-10-23 1999-05-06 Btg International Limited Controlled release formulations
WO2000044353A1 (en) * 1999-01-29 2000-08-03 Losan Pharma Gmbh Pharmaceutical compositions
WO2001066094A1 (en) * 2000-03-07 2001-09-13 Pharmatec International S.R.L. Controlled release oral solid forms containing mesalazine as active agent

Also Published As

Publication number Publication date
CA2544572A1 (en) 2005-07-14
US20120328698A1 (en) 2012-12-27
US8282958B2 (en) 2012-10-09
US20070154551A1 (en) 2007-07-05
JP4785000B2 (en) 2011-10-05
CA2544572C (en) 2012-10-09
JP2007515456A (en) 2007-06-14
WO2005063256A2 (en) 2005-07-14
EP1547601A1 (en) 2005-06-29
EP1729779A2 (en) 2006-12-13
US8501226B2 (en) 2013-08-06

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